Faich GA, Strobos J
Sodium ferric gluconate complex in sucrose: Safer than iron dextran.
ASN 30th Annual Meeting, San Antonio
J Am Soc Nephrol (Oct) 8:192A 1997

Iron dextran has been a useful agent to supply iron intravenously to patients on hemodialysis. However, the risk for allergy has somewhat limited its utilization. There is reason to believe that ferric gluconate, which has been used for over 30 years in Europe may be considerably safer. These authors reviewed databases throughout Europe, including the WHO, to determine reported episodes of significant reactions with this agent. The use of the agent in Germany and Italy alone was determined to be on the order of 2.5 million iv doses per year. The rate of reported reactions was 0.6 cases per million doses per year with ferric gluconate, compared to 1.2 reactions per million doses per year with iron dextran abstracted from comparable US sources. Importantly, there no reports of fatalities with ferric gluconate, compared to 46 with iron dextran.

Comment: These were obviously relatively crude techniques for comparing safety, however, the fact that there has never been a reported fatality with the use of ferric gluconate is quite important. I would expect that ferric gluconate should greatly replace the use of iron dextran when it becomes clinically available in the US. (Stephen Fishbane, M.D., Winthrop University Hospital, Mineola, NY)

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ASN 30th Annual Meeting, San Antonio
CRF by problem area : Anemia/Erythropoietin/Iron





The problem with iron gluconate is that it is a relatively unstable compound. That means that there is a risk of immediate iron toxicity, which has been demonstrated in animal experiments. The risk is diminished by giving as low doses as possible (<60 mg) and slow infusion (>10 minutes). Iron dextran and dextrin are stable and the risk of iron toxicity is very low. however, anaphylactoid reactions may rarely occur. Another alternative is iron saccharate (or sucrose) which is available in Europe. Stability is intermediate between gluconate and dextran and the risk for serious adverse events is extremely low. We have used iron saccharate for ten years without any problems.
Peter Bárány
Stockholm, Sweden-Tuesday, December 23, 1997 at 23:53:35 (PST)